The rapidly developing world of nanotechnology promises to revolutionize fields ranging from pharmaceuticals to computers to solar energy and beyond. But public interest groups, citing uncertainty about potential health and environmental risks, have grown increasingly vocal as nanotechnology-related products continue to reach the marketplace. The International Center for Technology Assessment (ICTA) has been a particularly aggressive advocate of increased nanotechnology oversight, openly demanding that the federal government “halt the commercialization of nanotechnology until products containing nanoparticles have been proven safe.” See Nanotechnology: Tiny Technology, Significant Risk,” http://www.icta.org/nanotech/index.cfm.  

Petition Demands Nanoparticle Regulation Under FIFRA

As part of this campaign, ICTA and more than a dozen other public interest groups filed a legal petition in May 2008 demanding that the Environmental Protection Agency (EPA) regulate all nanoparticle silver products (“nanosilver”) as pesticides under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). See Int’l Ctr for Tech. Assessment v. Johnson, http://www.icta.org/global/actions.cfm?page=15&type=364&topic=8. According to ICTA, nanosilver-containing products are being sold illegally and without the necessary regulatory steps “to address the human health and environmental impact challenges created by nanomaterials generally or nanosilver products specifically.” Arguing that nanosilver potentially poses toxic dangers to both humans and the environment, the ICTA petition outlines actions that EPA should take “immediately” to regulate nanosilver products.

Nanosilver Common in Consumer Goods

Because of silver’s antimicrobial properties, “large” silver particles have been used for decades in pesticides, disinfectants, and sanitizers. Nanosilver, however, has become the most ubiquitous nanomaterial in consumer products today. According to a September 2008 report by the Woodrow Wilson International Center’s Project on Emerging Nanotechnologies, products generating silver ions or containing nano-sized silver particles are one of the fastest growing categories of nanoproducts. Antimicrobial nanosilver can now be found in hundreds of different products, including such diverse items as air and water purifiers, bathroom cleaning products, stuffed children’s toys, baby bottles, laundry detergents, food storage containers, bandages, medical equipment, cutting boards, socks, underwear, suit fabrics, refrigerators, laundry machines, razors, linens, pillowcases, shoe inserts, toothbrushes, and computer keyboards.

Comprehensive Regulatory Action Possible

ICTA’s legal petition is remarkably ambitious in scope. First, the group argues that FIFRA requires manufactures to register all nanosilver-containing products with the EPA. The petition also contends that EPA should require nano-specific toxicity testing and risk assessments for all nanosilver-containing products. ICTA further claims that EPA is legally required to assess the human health and environmental risks associated with nanosilver, including a comprehensive review of all existing scientific studies and assessments of nanosilver’s potential impacts on children and infants. Moreover, the petition demands that EPA immediately prohibit sales of unregistered nanosilver products and, if necessary, pursue enforcement actions and civil penalties against current manufacturers and distributors. Crucially, ICTA argues that EPA must apply current pesticide requirements to nanosilver products, including (i) mandatory nano-specific ingredient and warning labels, and (ii) adequate disclosure of nanosilver’s potential environmental and health risks.

Public Comment Period

On November 19, 2008, EPA published a formal notice that it will accept written comments regarding ICTA’s petition. See Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides, 73 Fed. Reg. 69644. Comments must be provided by January 20, 2009. EPA’s notice includes instructions and procedures for comment submission.

Implications for Businesses

EPA’s solicitation of comments on the potential FIFRA regulation of nanosilver is important for two reasons. First, nanosilver product manufacturers could soon be forced to register their products as pesticides with EPA. Even consumer product manufacturers merely incorporating antimicrobial silver into household goods like appliances, clothing, toys, and other “treated articles” may find themselves required to submit health and environmental data, adopt nanomaterial-related warnings and labels, and stop sales until EPA approval is obtained.

More broadly, however, EPA’s solicitation of public comments about the intersection of nanosilver and  FIFRA may signal growing momentum toward federal regulation of nanotechnology as a whole. On October 31, 2008, for example, EPA gave public notice that carbon nanotubes could be considered new chemical substances subject to reporting and data submission requirements under the federal Toxic Substances Control Act (TSCA), even though other forms of carbon have long been registered and approved on the TSCA Inventory. See Toxic Substances Control Act Inventory Status of Carbon Nanotubes, 73 Fed. Reg. 64946. Within the past month, EPA has similarly taken steps to regulate specific silica and alumina nanoparticles as significant new uses under TSCA. See Significant New Use Rules on Certain Chemical Substances, 73 Fed. Reg. 65746, 65763 (Nov. 5, 2008).

The extent to which EPA ultimately regulates nanomaterials under FIFRA, TSCA, and other federal regimes remains to be seen. One thing, though, is certain: Regulatory interest in nanomaterials is on the rise. By taking a proactive approach and participating in the regulatory process, businesses can ensure that agencies make informed decisions and that the process yields the best possible outcome for all stakeholders.